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Database P P - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products To purchase documents on-line click on- -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
Database S S - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral Solution 12/17/98 N21007 Agenerase ...
author: Michael Lanthier
NDA-I1: NDA Approval Letter Tripathi: Please refer to your new drug application (NDA) dated December 22, 2000, received December 26, 2000, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Somavert (pegvisomant for injection) 10, 15, and 20 mgSomavert (pegvisomant for injection) for the treatment of acromegaly in...
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
NDA-I1: NDA Approval Letter Amino Acid Sequence of Pegvisomant Protein 50 Phe Pro Thr Ile Pro Leu Ser Arg Leu Phe Asp Asn Arg Ala Met Leu Arg Ala Asp Leu Asn Gln Leu Ala Phe Asp Thr Tyr Gln Glu Phe Glu Glu Ala Tyr Ile Pro Lys Glu Leu Gln Asn Pro Gln Thr Ser Leu Cys Phe Ser Glu Ser Ile Pro Thr Pro Ser Asn Arg Glu Glu Thr Gln Gln Lys Ser Asn Leu Glu Leu Leu Arg Ile Ser Leu Leu Leu Ile Gln Ser Trp Leu Glu...
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
NDA-I1: NDA Approval Letter page 9
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
NDA-I1: NDA Approval Letter page 8
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
NDA-I1: NDA Approval Letter page 2
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
NDA-I1: NDA Approval Letter page 1
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
CPMP Opinions CPMP Opinions - Substance/INN Invented Name Pharmaceutical form Strength Opinion Adoption Date Yttrium (90Y) chloride Ytracis Solution for radio labelling - 21/Nov/02 Vardenafil Levitra - - 21/Nov/02 ...
R & D Systems - Cytokine Bulletin Advanced Search Printer-friendly version Subscribe to the Cytokine Bulletin E-mail Insulin-Like Growth Factors and Cancer The association between circulating levels of serum or plasma insulin-like growth factor I (IGF-I) and cancer risk has been postulated for some time.
http://www.adis.com/files/newsletters/INP/Icov1441.pdf 17 CANCER Etanercept: sustained improvement in ankylosing spondylitis 11 Carboplatin/ paclitaxel/ trastuzumab in breast cancer 10 Nabumetone vs rofecoxib in knee OA 10 Cisplatin + temozolomide in glioblastoma multiforme 14 Pegvisomant launched in the UK for acromegaly 18 Leuprorelin injectable suspension approved in Mexico 18 Rofecoxib vs nabumetone in knee OA 10 Oxaliplatin as...
http://www.adis.com/files/newsletters/INP/Icov1424.pdf pylori eradication therapies effective in MALT lymphoma 14 Etanercept considered cost effective vs DMARDs in RA 5 Melphalan + thalidomide: high response in MM 12 Targeted treatment for rheumatoid arthritis 3 Mitotane: EU CPMP issues positive opinion 18 Paclitaxel- associated neuropathy not prevented by amifostine 17 NEUROLOGY Tamoxifen use influenced by adjuvant treatment guidelines...
Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since June 1998
Contents Vol. 2, No. 6, 2003 TM VolPegvisomant for the Treatment of Acromegaly 369- 374 WM Drake, PJ Trainer Review Articles Childhood Overweight: An Expanding Problem 375- 388 H Kaur, ML Hyder, WSC Poston Current and Future Strategies for the Management of Diabetic 389- 400 Neuropathy RA Malik Pharmacology of the Meglitinide Analogs: New...
author: Adis International Limited
subject: Treatments in Endocrinology
http://www.current-drugs.com/cdhome/cdmedia/coidpdf/vol3/no5may.pdf Current Opinion in Investigational Drugs Vol 3 No 5 May 2002 Paper alert 653 Taff Jones, Frank Barone, Mike Williams, Alan Palmer, Giovanna Damia, Robert E Hurst & Marc de Gasparo Patent selection 662 Hermann AM Mucke Patent alert 664 Neil Press, Hermann AM Mucke & Peter Norman Anti- infectives Antivirals (non- HIV) Edited by Barney Koszalka 680 Julia Watson Prospects for hepatitis C...
duplicates:http://www.current-drugs.com/cdmedia/coidpdf/vol3/no5may.pdf
http://www.current-drugs.com/cdhome/cdmedia/coidpdf/vol3/no5may.pdf page 1
duplicates:http://www.current-drugs.com/cdmedia/coidpdf/vol3/no5may.pdf
http://www.adis.com/files/newsletters/INP/ICOV1409.PDF 16 Interleukin- 2 in metastatic renal cancer 17 Letrozole effective after tamoxifen in breast cancer 13 Zoledronic acid beneficial in bone metastases 18 CARDIO/ VASCULAR ACE inhibitors/ NSAIDs: renal dysfunction 21 Antihypertensive treatment cost effective in high CV risk 4 Atorvastatin: pharmacokinetics reviewed 20 Hormone replacement therapy reduces ADMA levels 19 Stroke:...
NDA-I1: NDA Approval Letter page 3
author: CDER USER
subject: NDA Approval Letter - Approval letter based on enclosed/submitted labeli\ ng text
http://www.adis.com/files/newsletters/INP/ICOV1381.pdf CANCER Antineoplastics + ASCT in breast cancer too costly 5 Aprepitant approved by the US FDA 18 Busulfan granted marketing approval in the EU 17 SU 11248 associated with hair depigmentation 17 European collaboration on cancer guidelines suggested 4 CARDIO/ VASCULAR Alteplase: baseline MMP- 9 levels predict adverse events 13 Alteplase: model to predict benefit in stroke patients 10...
